Natural and Non-prescription Health Products Directorate (NNHPD) June 1, 2018-December 31, 2018 Engagement and Priorities

The following is an overview of anticipated NNHPD priorities and engagement opportunities. Please note that timelines may change due to shifting priorities.

The Directorate is committed to providing regular updates. The next update is expected in December 2018.

Visit us at What's New to find information on new priorities and engagement strategies.

1. Self-Care Framework

Health Canada is updating its approach to regulating self-care products with the aim of aligning the levels of oversight with risk to the consumer and helping consumers make better informed decisions.

Further to the feedback received during our 2016-2017 engagement activities, Health Canada will proceed with the update in phases, to reduce potential impacts on the marketplace and allow impacted stakeholders time to implement changes.

  • Phase I:  In Fall 2018, Health Canada will propose regulatory changes for improved labelling of natural health products (NHPs).
  • Phase II:  In early 2019, Health Canada will propose regulatory changes to introduce a risk-based approach to the oversight of non-prescription drugs.

At a future date, Health Canada intends to introduce further regulatory amendments to address evidence standards for similar health claims, extend risk-based regulatory oversight to NHPs and cosmetics, and seek additional powers for Health Canada.

For information on the next steps please visit: https://www.canada.ca/en/health-canada/services/self-care-framework.html

We will continue to engage Stakeholders as the regulatory proposals are developed.

2. Management of Applications Policy (MAP)

The NNHPD is undertaking updates to its policy on the Natural Health Products Management of Applications Policy (NHP MAP).  The NNHPD last updated its NHP MAP in 2014. Since then, the NNHPD has identified what works well, what can be improved, and what measures are needed to enhance the quality of applications and streamline the licensing process for NHPs. These measures have not yet been reflected in policy.  The policy updates are intended to align with current practice and achieve better results for the health and safety of Canadians. Stakeholders will be invited to provide their input into the updated draft document during a 60-day written feedback period beginning in September 2018. A consultation webinar will take place in late September 2018. The timetable for the updated policy is intended to align with the launch of the new web-based version of the product licence application (ePLA) in early 2019. Please refer to the calendar of engagement at the end of this document for upcoming engagement opportunities.

3. Plain Language Labelling (PLL)

A "lessons learned" session on the 1-year implementation of PLL for non-prescription drugs, took place on May 23, 2018 to incorporate internal and external feedback received, following the PLL implementation. As a result of this exercise, a draft updated Labelling Requirements for Non-prescription Drugs Guidance Document (formerly CDFT Guidance Document) was released on July 13 for consultation. This version incorporates feedback received in preparation and during the May 23rd session, the proposals for new font styles and Canadian Drug Facts Table (CDFT) headings and subheadings, as well as the new flexibility for Category I products as defined in the context of the Self-Care Framework (SCF). Stakeholders were invited to attend a webinar on July 20 to ask questions about the revised document and provide written feedback by July 30. We are continuing to work on monograph updates to facilitate the use of the proposed new PLL flexibility for Category I products. These revised monographs will be shared for consultation between August and October 2018. More details on engagement related to PLL is available at the end of this document.

4. Natural Health Products Reconsideration Process

The NNHPD has worked with the Food and Drugs Act Liaison Office (FDALO) to propose a new reconsideration process for NHP license refusals. The NHP reconsideration process will be harmonized with the human drug model where appropriate. The draft guidance document, Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions, was sent on June 25, 2018, to interested parties for a 60-day consultation period.  Following FDALO’s review of comments received, the guidance will be updated and posted in the Fall of 2018.  

5. Updates to the Natural Health Products Online Solution

In February 2018, the NNHPD released the revised electronic Amendment and Notification form for licensed NHPs. A webinar outlining the step-by-step process to use the new tool is anticipated in the Fall of 2018.

A web-based version of the product licence application (ePLA) form will be released in the Fall of 2018. Its development will be guided by the input received from previous engagement sessions and will ensure that it meets the needs of end users while satisfying the program's regulatory requirements. User testing with identified Stakeholders, will occur in August. Testing will be focused on the usability of the forms. Please refer to the calendar of engagement provided at the end of the document for more details.

6. Monograph Publication

Monograph updates constitute a continuous activity for the NNHPD. This includes the finalization of monographs currently in draft form and updates to existing monographs to improve clarity and comprehension.  Stakeholders will continue to be engaged on newly published and anticipated revisions to existing monographs. However, unanticipated revisions or those made in exigent circumstances, such as those resulting from pharmacovigilance activities, will continue to be published without consultation.

The Compendium of Monographs Guidance Document will be updated to reflect changes related to the “Statements to the Effect of” (STTEO). It will be posted for consultation in Fall 2018. Additionally, the NNHPD is working to update monographs to address the removal of the STTEO for Class I. This flexibility of wording introduced a level subjectivity that has been a source of attestation failures and cannot be validated by an IT system. For this reason and for ease of use, the NNHPD is transitioning towards the new electronic Product License Application (ePLA) and is adjusting monographs to allow data validation. There will be a drop-down menu with options to select from. Any deviations from the monographs will be reviewed in the Class II or III. We appreciate the thoughtful and analytical input provided by industry on claims for many of the monographs as part of this initiative.

On July 18, 2018, a teleconference call with interested Stakeholders was held to provide an update on how industry feedback was incorporated within monograph updates.

A list of monographs are set to be published in accordance with the following dates:

Monograph Bundles   Description Timeline
Bundle 1
  • Aloe Vera- Oral
  • Aloe Vera- Topical
  • Angelica
  • Calcium Potassium
  • Coenzyme Q10
  • Conjugated Linoleic Acid
  • Creatine Monohydrate
  • Ephedrine, L-
  • Figwort
  • Garlic
  • Gingko Biloba
  • Glutamine, L-
  • Hydrolized Collagen
  • Hyssop
  • Malabar Tamarind
  • Marshmallow - Leaf
  • Marshmallow - Root
  • Melatonin - Sublingual
  • Propolis - Topical
  • Propolis - Buccal
  • Propolis - Oral
  • Royal Jelly
  • Rutin
  • Spirulina
  • Turmeric - Oral
  • Turmeric - Topical

July 2018

Bundle 2
  • Acai - Euterpe oleracea 
  • Aloe vera Leaf Gel - Oral
  • Arginine, L-
  • Birch Weeping
  • Black Cohosh 
  • Black Horehound
  • Bovine Colostrum 
  • Caffeine 
  • Calendula - Buccal 
  • Calendula - Oral 
  • Calendula - Topical
  • Curcumin 
  • Fenugreek - Oral 
  • Fenugreek - Topical
  • Ginseng, American
  • Ginseng, Panax
  • Glucosamine sulfate
  • Grape Seed Extract 
  • Green Coffee Bean Extract
  • Green Tea Extracts
  • Maca
  • Melatonin - Oral
  • Milk Thistle
  • Peppermint
  • Red Clover
  • Red Wine Extract
  • Resveratrol
  • Thuja - Oral
  • Thuja - Topical
  • Ubiquinol
August 2018

Bundle 3

  • Borage Oil
  • Bromelain - Fruit
  • Bromelain - Stem
  • Chlorella
  • Cod Liver Oil
  • Evening Primrose Oil 
  • Fish Oil
  • Flaxseed Flaxseed oil
  • Joint Health Products
  • Kelp Products
  • Krill Oil
  • Multivitamin and minerals (MVM)
  • Pseudoephedrine - Adolescents and Adults
  • Pseudoephedrine - Children
  • Saw Palmetto 
  • Saw palmetto, liposterolic extract 
  • Seal Oil
  • Selenium
  • Serrapeptase
September 2018

Bundle 4

  • 5-HTP
  • Bilberry - Buccal 
  • Bilberry - Oral 
  • Black Pepper - Piper nigrum
  • Black Walnut - Juglans nigra
  • Blessed Thistle - Oral 
  • Blessed Thistle - Topical
  • Burdock - Oral
  • Burdock - Topical
  • California poppy
  • Cascara Sagrada
  • Cayenne - Oral
  • Cayenne - Topical
  • Chamomile, German - Buccal
  • Chamomile, German - Oral
  • Chamomile, German - Topical
  • Chamomile, Roman 
  • Chaste tree 
  • Dandelion
  • Dandelion Juice
  • Deglycyrrhizinated licorice -
  • Buccal Deglycyrrhizinated licorice - Oral
  • Fennel, Bitter
  • Fennel, Sweet
  • Ginger 
  • Ground Ivy - Oral 
  • Ground Ivy - Topical
  • Kutki - Picrorhiza kuuooa
  • Psyllium - Plantago afra 
  • Psyllium - Plantago arenaria 
  • Psyllium -Plantago ovata 
  • Sage - Buccal
  • Sage - Oral
October 2018

Bundle 5

  • Amla - Phyllanthus emblica 
  • Carnitine, L-
  • Cassia cinnamon - Cinnamomum
  • aromaticum
  • Chitosan
  • Cinnamon
  • Cranberry
  • Cranberry juice, dried 
  • Devil's Claw 
  • Echinacea Angustifolia
  • Echinacea pallida
  • Echinacea purpurea
  • Eleuthero 
  • Globe artichoke
  • Holy Basil - Leaf
  • Holy Basil - Seed 
  • Hops
  • Horse Chestnut 
  • Horseradish
  • Licorice
  • Lysine                      
  • Maitake 
  • MSM 
  • Olive leaf - Olea europaea
  • Passionflower 
  • Pomegranate
  • Rosemary - Oral
  • Rosemary - Topical
  • Senna              
  • Skullcap
  • St. John's Wort - Oral 
  • St. John's Wort - Oral - Hydroalcoholic
  • Extract 
  • St. John's Wort - Topical
November 2018

Bundle 6

  • Acne Therapy
  • Anti-Dandruff
  • Antiseptic Skin Cleansers
  • Diaper Rash
  • First aid antiseptic
  • Medicated Skin Care
  • Oral Health
  • Primary Sunscreen
  • Secondary Sunscreen      
December 2018

Bundle 7

  • 3,3'-diindolylmethane (DIM) 
  • Active hexose correlated compound - Granule (AHCC-FG)  
  • Active hexose correlated compound - Powder (AHCC-FD)  
  • African Wild Mango  
  • Alfalfa  
  • Amylase, alpha-
  • Arnica - semisolid dosage forms 
  • Arnica 
  • Ashwagandha 
  • Astragalus  
  • Avens
  • Bearberry - Arctostaphylos uva-ursi
  • Birch, White
  • Boldo
  • Caraway
  • Carrot 
  • Cellulase 
  • Chymotrypsin
  • Ephedra 
  • European Pennyroyal 
  • Frankincense - Oral 
  • Frankincense - Topical
  • Galactosidase, alpha- 
  • Gentian 
  • Indole-3-carbinol 
  • Lactase
  • Linden, European
  • Linden, Large - leaf
  • Linden, Small - leaf
  • Papain
  • Stinging Nettle
  • Stinging Nettle - Juice
January 2019

Bundle 8

  • Beta-Glucan 
  • Betaine / Betaine hydrochloride 
  • Blueberry 
  • Catnip  
  • Chondroitin Sulphate  
  • Citrus Bioflavonoids 
  • Dong quai - Angelica sinensis 
  • Elder - Sambucus 
  • Feverfew 
  • Glucomannan - Capsule 
  • Glucomannan - Powder 
  • Glucosamine hydrochloride
  • Goldenseal - Buccal 
  • Goldenseal - Oral 
  • Hamamelis Water - Buccal
  • Hamamelis Water - Ophthalmic
  • Hamamelis Water - Topical
  • Hawthorn - Crataegus laevigata
  • Hawthorn - Crataegus monogyna
  • Heal-all - Buccal 
  • Heal-all - Oral 
  • Heal-all - Topical 
  • Inulin
  • Juniper
  • Lipase
  • Male Genital Desensitizers
  • Mugwort
  • Protease, Fungal 
  • Rhodiola 
  • Tribulus
  • Trypsin
February 2019

Bundle 9

  • Alpha lipoic acid, DL-
  • Free Plant Sterols
  • Lecithin
  • Lemon Balm 
  • Lungwort - Oral
  • Lungwort - Topical 
  • N-Acetyl-L-Cysteine 
  • Pancreatic Enzymes 
  • Para Aminobenzoic Acid
  • Phosphatidylserine
  • Plant Stanol Esters
  • Plant Sterol Esters
  • Poria  
  • Pygeum
  • Quercetin
  • Reishi - Ganoderma lucidium 
  • Soy Flour 
  • Soybean Extracts and Isolates 
  • Taurine
  • Theanine, L-  
  • Thyme - Buccal 
  • Thyme - Oral
  • Thyme - Topical
  • Tomato Extract
  • Tyrosine, L-  
  • Valerian 
  • White Kidney bean extract 
  • White willow
  • Witch Hazel - Buccal 
  • Witch Hazel - Oral 
  • Witch Hazel - Topical
March 2019

Bundle 10

  • Antioxidants
  • Aromatherapy - Essential Oils
  • Benzocaine
  • Cognitive Function Products
  • Corn & Callus Remover
  • Counterirritants
  • Digestive Enzymes
  • Flower Essence
  • Gemmotherapy
  • Homepathy
  • Hydrocortisone Topical
  • Laxative, Carbon Dioxide Releasing
  • Laxative, Hyperosmotic
  • Lithotherapy

April 2019

Bundle 11

  • Marigold Extracts and isolates
  • Medicated Vapours
  • Mushrooms
  • Nosodes
  • Oil Products
  • Oligotherapy
  • Organotherapy
  • Probiotics
  • Traditional Chinese Medicine
  • Ingredients
  • Triphala
  • Wart Remover
  • Whey Products
  • Workout Supplements
May 2019

7. Proactive Risk Management Projects

Quality of NHPs

As a result of the conclusions from the 2017-2018 Compliance Monitoring Project (CMP), the NNHPD is examining its approach regarding pre-market review of quality. Further details will be made available in late 2018-early 2019.

Next Proactive Risk Management Project

Another CMP, newly renamed Proactive Risk Management Project (PRMP) will be launched this year and include on-site visits to verify Good Manufacturing Practices (GMP) compliance of NHP sites.

8. Licensed Natural Health Products Database Data Extract (LNHPD)

A new self-serve Application Programming Interface (API) will be launched in Fall 2018 as part of the Open Governmental portal. The new portal will allow Stakeholders to extract data on demand in two different formats; JSON and XML. The previous text based extract will still be available for Stakeholders to access, however, it will not be updated with new information and users will be directed to the newer API, which will be located on the portal, for up to date information. Users are encouraged to reconfigure their software interfaces, if needed, to better utilize the format of their choice.

9. Appropriate Dosage Forms for Children

NHPs with solid dosage forms, such as tablets and capsules, may not be suitable for children less than 6 years of age if the product label does not provide specific instructions of use. Since May 2017, the NNHPD has been requesting, from impacted licence holders, that specific instructions for use in children be added to the label of already licensed products. The next phase of the initiative is expected to begin in Summer 2018 and will focus on Class II and III products (approximately 115 natural health products) with solid dosage forms for children.

10. Disinfectants

Concurrent with Phase II of the Self-Care Framework (SCF), the NNHPD will propose, in early 2019, a separate and discrete set of amendments under the Food and Drug Regulations to formalize current practice for hard surface disinfectants.

The guidance document Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs, came into force on March 1, 2018. It will be implemented for disinfectants as of April 1, 2019. This guidance document replaces Changes in Manufacturer's Name and/or Product Name with the end goal of developing consistent practices around administrative drug submissions.  The new document will clarify the requirements for eligible drug submissions and applications that will be processed under the administrative pathway.

Upcoming Engagement

Priority Description Estimated Timeline Targeted Audience
Self-Care Framework Consultation of industry and health professional Stakeholders regarding the proposed improvements to the labelling of NHPs, including discussions on costs and time to implement changes. Ongoing Industry and Health Professionals
Consultation with consumers on proposed improvements to the labelling of NHPs. Summer 2018 Consumers
Consultation with industry and health professional Stakeholders, regarding the proposed regulatory amendments to introduce a risk-based approach for non-prescription drugs. Fall 2018 Industry and Health Professionals
Public consultation on regulatory amendments to the Natural Health Products Regulations for improved labelling of NHPs (pre-publication in Canada Gazette, Part I). Fall 2018 Consumers
Public consultation on regulatory amendments to the Food and Drug Regulations to introduce a risk-based approach to the oversight of non-prescription drugs (pre-publication in Canada Gazette, Part I). Spring 2019 Consumers
Management of Applications Policy Draft policy will be shared by email for written feedback. September 2018 Industry associations and interested applicants
Webinar to answer and clarify questions on the draft policy. Fall 2018
Final policy document posted online to align with the launch of the new ePLA. Early 2019
Plain Language Labelling (PLL) Labelling Requirements for Non-prescription Drugs Guidance Document released for comment. July 13, 2018 Industry Stakeholders
Webinar to discuss Labelling Requirements for Non-prescription Drugs Guidance Document. July 20, 2018
Labelling Requirements for Non-prescription Drugs Guidance Document stakeholder feedback due. July 30, 2018
Monographs released in batches for feedback. August - October 2018
Publishing of the Good Label and Package Practices Guide (GLPPG), CDFT Guidance, eCDFT guidance, and Questions and Answers Document. September 2018
Roll-out of Category I (Self-Care) flexibilities for non-prescription drugs. December 2018
Natural Health Products Reconsideration Process Consultation on the proposed process. June - August 2018 Industry Stakeholders
Finalization of the Guidance Document Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs. Fall 2018
Updates to the Natural Health Products Online Systems Teleconference call with update on industry feedback within the monograph updates. July 18, 2018 Industry Stakeholders
Electronic Product Licence Application (ePLA) testing with Associations and Applicants. August 2018 Industry Stakeholders
Compendium of Monographs Guidance Document posted for consultation. Fall 2018 Industry Stakeholders
Webinars outlining the step-by-step process to use the new tools. September and October 2018 Industry Associations
Release of a web and improved version of the Electronic Product Licence Application (ePLA) Form. Late 2018, Early 2019 Industry Associations
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